Status:
COMPLETED
Prospective Cytochrome P450 Genotyping and Clinical Outcomes in Patients With Psychosis
Lead Sponsor:
Northwell Health
Conditions:
Schizophrenia
Schizoaffective Disorder
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
The aim of the study is to examine whether determining treatment strategies based upon Cytochrome P450 2D6 (CYP2D6) genotype will improve drug response rates and clinical outcome in patients with psyc...
Detailed Description
Recent large scale clinical trials have demonstrated that a substantial proportion of patients with psychotic disorders, such as schizophrenia and bipolar disorder, discontinue their antipsychotic med...
Eligibility Criteria
Inclusion
- Age 18-60;
- DSM-IV(Diagnostic and Statistical Manual of Mental Disorders, Fourth Edition) diagnosis of schizophrenia, schizoaffective disorder, schizophreniform disorder, or psychotic disorder NOS (Not otherwise specified), bipolar disorder with psychotic features
- Having moderate to severe psychotic symptoms resulting in inpatient admission
- Able to provide informed consent
Exclusion
- Evidence of serious medical conditions,
- Evidence of liver disease, as shown in elevated liver function test
- Female patients who are pregnant or breast feeding;
- History of allergic reactions to risperidone or Invega;
- History of risperidone or Invega treatment failure.
- History of receiving any long-acting injectable form of antipsychotic medications such as haloperidol decanoate, fluphenazine decanoate, Risperdal Consta, Invega Sustenna, and Zyprexa IntraMuscular in the past two months.
- History of treatment with clozapine.
- Medications that potentially interfere with the CYP450 2D9 enzyme family, including bupropion, fluoxetine, paroxetine, duloxetine, sertraline, cinacalcet, quinidine, terbinafine, amiodarone, and cimetidine, and as per clinical review by study physicians.
- Patients who are not able to provide informed consent due to impairment in decision-making capacity.
Key Trial Info
Start Date :
September 23 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2018
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT01878513
Start Date
September 23 2009
End Date
July 31 2018
Last Update
August 27 2018
Active Locations (1)
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1
Zucker Hillside Hospital
Glen Oaks, New York, United States, 11004